Europe Phases Out COVID-19 Flexible Regulations

The European Medicines Agency (EMA) announced on July 6, 2023 that the agency, the European Commission (EC), and the Heads of Medicines Agencies (HMA) are starting the process for ending regulatory flexibilities for medicines that were put in place during the COVID-19 pandemic. This action follows the World Health Organization’s end to the public health emergency.

The European regulators put these measures into place in the areas of marketing authorizations, API and finished product manufacturing, quality requirements, and related regulatory procedures. This was done to mitigate disruptions to the drug supply chain that might have been caused by delays in facility inspections and other procedures. These measures will now be phased out, according to EMA.

“From now on, the regulatory flexibilities that were introduced jointly by the HMA, EC, and EMA specifically during the COVID-19 pandemic should no longer be granted. For already approved labelling flexibilities, e.g., the English-only labelling for COVID-19 vaccines, their application will be extended until the end of 2023, in order to ensure a smooth phase-out and avoid any supply difficulties or other disruptions due to a sudden change in applicable requirements. After 2023, the regular mechanisms foreseen in the legislation in relation to labelling exemptions should be followed,” the agency stated in a press release.

EMA also stated that on-site good manufacturing (GMP) and distribution practice (GDP) inspections have restarted that were either previously postponed or done remotely during the pandemic. The validity of GMP and GDP certificates has been extended to the end of 2023, and the approach to 2024 certificates will be discussed by the GMDP Inspectors Working Group in upcoming months. “This Group has also reviewed experiences with remote working arrangements of qualified persons during the pandemic, and will issue guidance on how those specific arrangements can be applied in the future,” EMA stated in the release.

The agency went on to say that experiences learned through the handling of the pandemic will be collected and considered so the agency can inform best practices for future health challenges.

Source: EMA